pancreas metastatic tumor MedDRA version: 9.1 Level: HLT Classification code 10033632
Conditions
Interventions
Trade Name: METFORMINA TEVA*100CPR 850MGTR
Pharmaceutical Form: Tablet
INN or Proposed INN: Metformin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 850-
Trade Na
Sponsors
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -cytologic and istologic diagnosis of pancreatic adenocarcinoma; -presence of metasatasis; -absebce of crebral metastasis with symptoms; -age between 18-75 yeras old (71-75 only if KPS>70%); -Karnofsky PS > 60 ; -measurable disease; -GB > 3500/mm3, neutrofili > 1500/mm3; Plt > 100000/mm3; Hb > 10 g/dl; -creatinine =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -previous metformine assumption; -previous or concomitant malignant tumors, apart from carcinoma in sito of the uterine cervix and epitelial malignant tumors adeguately treated or other malignant tumors if patiet was free from pathology from almost 5 years ; -pregnancy and breast feeding; -counter-indications for chemiotherapic treatment (acute heart attack 4 months before the study enrollment, heart failure; -alcool abuse;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the portion of patients free by progression after 6 months (PFS-6) from randomization date in patients treated with PEXG with metformine vs patients treated only with PEXG.;Secondary Objective: Evaluation of the global survival, rate of objective radiologic responses, rate of bioumoral resposnses , duration of responses and toxicity of the two treatment under study;Primary end point(s): progression patology free at 6 months in patients treated with PEXG+metformine vs patients treated only with PEXG | — |
Countries
Italy
Outcome results
None listed